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中国循证儿科杂志

中国循证儿科杂志 ›› 2016, Vol. 11 ›› Issue (3): 215-218.

• 论著 • 上一篇    下一篇

聚乙二醇4000治疗8岁以下儿童便秘安全性和疗效的系统评价

寇温1，杨天宁2，武新安1   

  1. 兰州大学第一医院 1药剂科；2 肿瘤内科 兰州，730000
  • 收稿日期:2016-04-12 修回日期:2016-06-25 出版日期:2016-06-25 发布日期:2016-06-25
  • 通讯作者: 武新安

Safety and efficacy of PEG4000 in constipated children younger than 8 years: a systematic review

KOU Wen1, YANG Tian-ning2, WU Xin-an1   

  1. 1 Department of Pharmacy, 2 Department of Oncology, First Hospital of Lanzhou University, Lanzhou 730000, China
  • Received:2016-04-12 Revised:2016-06-25 Online:2016-06-25 Published:2016-06-25
  • Contact: WU Xin-an

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摘要：

目的 评价聚乙二醇(PEG)4000治疗<8岁儿童便秘的安全性和有效性。方法 计算机检索PubMed、EMBASE、Cochrane 图书馆、中国知网和维普数据库，检索起止时间为1981年1月1日至2016年4月1日，获得PEG4000治疗<8岁儿童便秘的RCT文献，评估纳入文献的偏倚风险。评估PEG4000治疗期间的安全性和疗效指标。采用 RevMan 5.0软件行Meta分析。结果 4篇RCT文献进入系统评价，共纳入344例<8岁便秘患儿，观察时间为2~12周，PEG4000与乳果糖、氧化镁和PEG-电解质对照的文献分别为2、1和1篇。4篇文献均描述了随机序列的产生、分配隐藏和受试者的脱落或失访，3篇文献采用双盲法。因对照组和结局指标不同行描述性分析，①4篇文献PEG4000治疗期间均未观察到严重不良事件，1篇文献显示PEG4000组治疗12周至少1项血生化指标异常的比例与治疗前基线数据差异无统计学意义（35/39 vs 31/39），1篇文献显示腹泻发生率低于氧化镁对照组(2/46 vs 12/43)，1篇文献显示恶心发生率低于PEG-电解质对照组(1/49 vs 9/42)。②1篇文献显示用药后4周每天大便次数PEG4000组与乳果糖对照组差值为0.36次（95%CI:0.16~0.56次），1篇文献显示用药后12周每周大便次数PEG4000组和乳果糖对照组相近（8.5 vs 11.5次）。治疗4周后好转率率PEG4000组优于氧化镁对照组(42/46 vs 28/43， P=0.003）；治疗4周后每周大便次数PEG4000组优于PEG-电解质对照组，(9.2 ± 3.2) vs (7.8 ±2.4) 次，P=0.025。结论 现有临床证据表明，PEG4000治疗<8岁儿童便秘的安全性和疗效较好。

Abstract:

Objective To assess the efficacy and safety of polyethylene glycol 4000 (PEG4000) in constipated children younger than 8 years.Methods The randomized controlled trials of PEG4000 compared with other active comparator in children younger than 8 years with primary chronic constipation were conducted by an electronic search of Cochrane library, PubMed, EMBASE, ISI Web of Science, VIP, and CNKI, with the retrieval time from January 1981 to April 2016. Results Four qualifying studies involving 344 children were identified. Two were comparisons of PEG4000 with lactulose, one with milk of magnesia and one with PEG-electrolyte(PEG-EL). Study duration ranged from 2 weeks to 12 weeks. Four studies described the generation of random sequence, the allocation concealment and reported the subjects lost to follow-up, 3/4 articles used double-blind method. ①There was no severe adverse reaction observed in four studies. The rate of at least one blood biochemical indexes outside normal of PEG4000 was similar between after and before treatment(35/39 vs 31/39). The incidence of diarrhea was lower in PEG4000 group (2/46 vs 12/43) than in milk of magnesia group; the incidence of nausea was lower in PEG4000 group compared to PEG-EL group (1/49 vs 9/42). ②The stool frenqency was similar in PEG4000 and lactulose groups(8.5 vs 11.5 per week), after four weeks follow up, PEG4000 group had great increase in stool frenqency than PEG-EL group［(9.2 ± 3.2) vs (7.8 ±2.4) times，P=0.025］ and PEG4000 group had significantly higher improvement compared with the patients in the milk of magnesia group (42/46 vs 28/43，P=0.003).Conclusion Limited scientific evidence demonstrated that for children younger than 8 years , PEG4000 use was more effective and tolerated than other active comparators.